Efficacy and Safety of Nebivolol (Added to Lisinopril or Losartan) in Hypertensive Patients - Full Text View

Sponsor:	Forest Laboratories
Information provided by:	Forest Laboratories
ClinicalTrials.gov Identifier:	NCT00734630

Purpose

This study will assess blood pressure reduction with nebivolol or placebo in patients taking lisinopril or losartan.

Condition	Intervention	Phase
Hypertension	Drug: nebivolol Drug: lisinopril, losartan	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Nebivolol Added To Antihypertensive Treatment With Lisinopril or Losartan in Patients With Hypertension.

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Lisinopril Nebivolol Losartan Losartan potassium

U.S. FDA Resources

Further study details as provided by Forest Laboratories:

Primary Outcome Measures:

Change from baseline in mean seated trough cuff systolic blood pressure (SBP) at Week 12 [ Time Frame: Before treatment and 12 weeks after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in mean seated trough cuff diastolic blood pressure (DBP) at Week 12. [ Time Frame: Before treatment and 12 weeks after treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	450
Study Start Date:	August 2008
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Encapsulated Nebivolol 5mg, 10mg, 20mg, or 40mg total daily dosage, oral administration once daily	Drug: nebivolol Encapsulated Nebivolol 5mg, 10mg, 20mg, or 40mg total daily dosage, oral administration once daily
2: Placebo Comparator Placebo Comparator Lisinopril 10mg, 20mg total daily dosage, oral administration Placebo Comparator Losartan 50mg, 100mg total daily dosage, oral administration	Drug: lisinopril, losartan Lisinopril 10mg, 20mg total daily dosage, oral administration Losartan 50mg, 100mg total daily dosage, oral administration

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female, ambulatory outpatients 18-85 years old at screening
Have a history of hypertension
Qualifying laboratory results

Exclusion Criteria:

Severe hypertension, including chronic kidney disease
Documented congestive heart failure
Have clinically significant respiratory, liver, or heart disease
History of stroke, heart attack, or heart surgery in the last 6 months
Have a history of hypersensitivity to nebivolol or other beta blockers.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00734630

Contacts

Contact: Sandra Beaird, PhD

800-678-1605 ext 66297

info@forestpharm.com

Show 31 Study Locations

Sponsors and Collaborators

Forest Laboratories

Investigators

Study Director:

Manfred Stapff, MD, PhD

Forest Research Institute, a subsidiary of Forest Laboratories, Inc.

More Information

No publications provided

Responsible Party:	Forest Research Institute, a Subsidairy of Forest Laboratories, Inc. ( Carol Satler MD, PhD Vice President, Clinical Development, Cardiovascular & Respiratory )
Study ID Numbers:	NEB-MD-11
Study First Received:	August 13, 2008
Last Updated:	September 1, 2009
ClinicalTrials.gov Identifier:	NCT00734630 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Forest Laboratories:

nebivolol
Bystolic ™
lisinopril
losartan
Hypertension

Additional relevant MeSH terms:

Neurotransmitter Agents
Vasodilator Agents
Losartan
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Cardiotonic Agents
Physiological Effects of Drugs
Lisinopril
Vascular Diseases
Nebivolol
Enzyme Inhibitors
Cardiovascular Agents

Antihypertensive Agents
Protective Agents
Pharmacologic Actions
Protease Inhibitors
Angiotensin II Type 1 Receptor Blockers
Therapeutic Uses
Adrenergic beta-Antagonists
Angiotensin-Converting Enzyme Inhibitors
Adrenergic Antagonists
Cardiovascular Diseases
Anti-Arrhythmia Agents
Hypertension

ClinicalTrials.gov processed this record on February 08, 2010